Ketoconazole Foam 2% for the Treatment of Versicolor
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|ClinicalTrials.gov Identifier: NCT00830388|
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : August 22, 2012
Last Update Posted : August 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tinea Versicolor||Drug: Ketoconazole 2% Foam||Phase 4|
- To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
- To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
- To assess treatment satisfaction as rated by patients
This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketoconazole Foam 2% for the Treatment of Versicolor|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Ketoconazole 2% Foam
Drug: Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Other Name: Extina Foam
- The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ]Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.
- To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. [ Time Frame: 4 weeks ]Adverse events were used to assess safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830388
|United States, Alabama|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Boni E Elewski, MD||University of Alabama at Birmingham|